Proper cleaning procedures and maintenance are crucial to preserving the cleanliness, contamination control, and efficiency of cleanroom processes. Each cleanroom receives a different cleanliness classification based on the industrial application that the cleanroom operates in, as well as other environmental considerations. Each cleanroom class has a slightly different protocol when it comes to gowning, protocol, and supplies. For ISO 7 (Formerly Class 10,000) cleanrooms, these gowning requirements need careful consideration.
What Is a Cleanroom?
A cleanroom is a controlled environment where workers perform certain industrial activities. Usually, employees pack, manufacture, and assemble products such as medical devices, semiconductors, touch screens, and implantable devices. Aerospace, pharmaceuticals, electronics and medical equipment manufacturers may all use cleanrooms to package their products.
In a cleanroom, the regulations eliminate airborne contamination from people, equipment, facilities, and industrial processes. The more stringent the cleanroom classification, the more sterile the air will be within the cleanroom. Lower ISO classifications, such as ISO 4 or 5, have a higher level of cleanliness than higher ISO classifications, such as ISO 7 or 8. Nevertheless, each classification has a set of requirements that every employee must adhere to. These regulations include gowning requirements.
Why Is Proper Gowning Important in Cleanrooms?
Gowning refers to a set of personnel protective clothing that workers must wear whenever they are in a cleanroom. These gowning requirements can cover any of the following body parts:
- Legs and pants
- Head and hair
- Beard and mustache
- Feet and shoes
- Torso and upper body
By utilizing proper gowning procedures, cleanroom employees can cover all parts of their body that have a potential for contamination. Particles coming from hair, skin cells and clothing fibers can easily become airborne and shed in the cleanroom environment. This could lead to contamination of the environment and the product. If the product risks contamination, the whole operation is at risk.
What are the ISO 7 Cleanroom Gowning Requirements?
If you are entering an ISO 7 cleanroom, it is vital to follow the facility’s gowning requirements. In most ISO 7 facilities, you and anyone else entering the cleanroom must completely cover your hair using a bouffant. You should also cover your ears using the bouffant. If you have any facial hair, you will have to don a beard cover as well. You will also need to cover your shoes with shoe covers. Electrostatic dissipative shoe covers are available for grounding when working in and around sensitive electronics In some cleanrooms, you may also have to wear gloves.
In addition, you will have to wear a protective frock in the cleanroom. Using a cleanroom-approved stainless steel gowning rack and hanger can help you avoid contamination of the frock during the gowning process. To carefully place the frock on your body, zip the frock all the way up or snap all applicable snaps. If you have to wear gloves, make sure you pull them over the cuff areas of your gown.
Tips for a Safe Cleanroom Etiquette
You should only allow trained and authorized personnel in your cleanroom. Ensure that all movement is deliberate and slow. Limit all running, horseplay, or contaminating activities. Do not allow any eating, drinking, gum, or tobacco in your cleanroom. If you notice contamination on any of your cleanroom gowns, ensure that the worker changes the gown immediately.